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TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

Primary Purpose

Pancreatic Cancer, Colorectal Cancer, Rectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TGR-1202
nab-paclitaxel + gemcitabine
Oxaliplatin + Folinic acid + Fluorouracil
Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed:

    1. adenocarcinoma of the pancreas (pancreatic cancer)
    2. adenocarcinoma of the colon or rectum (colorectal cancer)
    3. adenocarcinoma of the gastric (gastric cancer)
    4. esophageal cancer
    5. gastrointestinal stromal tumor (GIST)
  • Relapsed or refractory disease
  • Measurable lesion by RECIST 1.1

Exclusion Criteria:

  • Known Hepatitis B, C or HIV infection
  • Previous therapy with any drug that inhibits the PI3K pathway
  • Anti-tumor therapy within 21 days of study Day 1

Sites / Locations

  • TG Therapeutics Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

TGR-1202

TGR-1202 + nab-paclitaxel + gemcitabine

TGR-1202 + FOLFOX

TGR-1202 + FOLFOX + Bevacizumab

Arm Description

TGR-1202 daily dose

TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion

TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)

TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion

Outcomes

Primary Outcome Measures

Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary Outcome Measures

Overall Response Rate
Overall response rate with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Duration of Response
Duration of response with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).
This endpoint will measure the plasma PK profile of TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)

Full Information

First Posted
October 1, 2015
Last Updated
October 1, 2019
Sponsor
TG Therapeutics, Inc.
Collaborators
SCRI Development Innovations, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02574663
Brief Title
TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
Official Title
A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
Collaborators
SCRI Development Innovations, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.
Detailed Description
TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Colorectal Cancer, Rectal Cancer, Gastric Cancer, Esophageal Cancer, Gastrointestinal Stromal Tumor (GIST)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TGR-1202
Arm Type
Experimental
Arm Description
TGR-1202 daily dose
Arm Title
TGR-1202 + nab-paclitaxel + gemcitabine
Arm Type
Experimental
Arm Description
TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
Arm Title
TGR-1202 + FOLFOX
Arm Type
Experimental
Arm Description
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)
Arm Title
TGR-1202 + FOLFOX + Bevacizumab
Arm Type
Experimental
Arm Description
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion
Intervention Type
Drug
Intervention Name(s)
TGR-1202
Intervention Description
TGR-1202 oral daily dose
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel + gemcitabine
Other Intervention Name(s)
Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin + Folinic acid + Fluorouracil
Other Intervention Name(s)
Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
Other Intervention Name(s)
Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Description
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Time Frame
Up to 28 days after the last patient enrolled
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall response rate with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Time Frame
Up to 1 year
Title
Duration of Response
Description
Duration of response with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Time Frame
Up to 1 year
Title
Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).
Description
This endpoint will measure the plasma PK profile of TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Time Frame
At selected timepoints up through 6 months
Title
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
Time Frame
At selected timepoints up through 6 months
Title
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)
Time Frame
At selected timepoints up through 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed: adenocarcinoma of the pancreas (pancreatic cancer) adenocarcinoma of the colon or rectum (colorectal cancer) adenocarcinoma of the gastric (gastric cancer) esophageal cancer gastrointestinal stromal tumor (GIST) Relapsed or refractory disease Measurable lesion by RECIST 1.1 Exclusion Criteria: Known Hepatitis B, C or HIV infection Previous therapy with any drug that inhibits the PI3K pathway Anti-tumor therapy within 21 days of study Day 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Bendell, MD
Organizational Affiliation
Sarah Cannon Research Instititue (SCRI)
Official's Role
Study Chair
Facility Information:
Facility Name
TG Therapeutics Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

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